Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-03-11 @ 4:09 PM
Study NCT ID:
NCT02279706
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)', 'timeFrame': 'up to 4weeks', 'description': 'Check the Korean version of rhinitis controlled assessment tests'}], 'secondaryOutcomes': [{'measure': 'rhinitis-related quality of life', 'timeFrame': 'up to 4weeks', 'description': 'rhinitis-related quality of life (RQLQ)check up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).', 'detailedDescription': 'Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'rhinitis within 12 months from the time of study enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults over 19 years\n2. Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .\n3. People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.\n4. People who have rhinitis symptoms requiring medication at the time of study enrollment.\n5. People who can read and write korea language.\n6. People who signed a written consent form approved by the Institutional Review Board of their respective organizations to participate in this study freely hearing to explain fully the purpose for the contents of this study prior to participation in research.\n\nExclusion Criteria:\n\n1. People diagnosed with Rhinitis medicamentosa.\n2. People determined that bacterial or viral respiratory infection at the time of study enrollment.\n3. People who have evidence of nasal infection\n4. People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.\n5. People determined that acute or chronic sinusitis according to the researchers determined.\n6. In case that pregnancy test is positive, or ambiguous conclusions among female patients.\n7. people deemed unsuitable for clinical trial participation due to other reasons.'}, 'identificationModule': {'nctId': 'NCT02279706', 'acronym': 'R-CAT', 'briefTitle': 'Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Linguistic Adaptation of Rhinitis Control Assessment Test (RCAT) in Korean and Responsiveness to Disease Severity, Quality of Life, and Treatment in Adult Rhinitis Patients: A Multicenter Prospective Study', 'orgStudyIdInfo': {'id': 'MED-OBS-14-158'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'otherNames': ['questionnaire(R-CAT-RQLQ)'], 'description': 'Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'hae sim park, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of internal medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, Department of allergic interal medicine', 'investigatorFullName': 'Hae-Sim Park', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}